Description
HIV screening test (the virus responsible for AIDS) performed using a blood sample from a fingertip.
This is a reliable self-test for diagnosing HIV infections that occurred at least three months prior.
Autotest VIH is a single-use in-vitro diagnostic device.
Autotest VIH can be performed by non-expert individuals in a private setting.
The test takes approximately 5 minutes to perform, and the waiting time before reading the result is 15 minutes.
A watch or other time-measuring device is required.

Instructions for use
1. Place the test tube holder on a flat surface. Gently pull the cap containing the buffer solution to separate it from the self-test. Slide it with a finger to the bottom of the test tube holder.
2. Wash your hands, preferably with warm water, and dry them. Open the sachets containing the disinfectant wipe and the sterile gauze. Rub the disinfectant wipe on the fingertip and wait for it to dry. Remove the cap from the safety lancet. Place the red end of the lancet on the fingertip and push firmly downwards to puncture the skin with the needle.
Gently squeeze the finger to form a first large drop of blood. Remove the drop with the sterile gauze. Without pressing too hard, gently squeeze the finger again to form another large drop of blood. With the self-test pointing downwards, touch the drop of blood with the tip of the device until the pointed end is filled with blood.
3. Ensure that the test tube holder containing the cap with the buffer solution is placed on a flat surface. Holding the self-test with the tip facing downwards, firmly insert it into the test tube holder so as to puncture the aluminum membrane of the buffer solution cap.
Push firmly downwards (you will hear 3 clicks). Check for the appearance of a pink spot, which should start to be visible in less than one minute after the test device and the cap with the buffer solution have been inserted into each other. Apply the plaster to the finger.
4. Check the time and wait 15 minutes before reading the result.
Non-reactive self-test: appearance of one line: control line (HIV negative).
Reactive self-test: appearance of two lines: control line and test line (probably HIV positive).
If positive:
- consult a doctor as soon as possible, informing them that you have just performed an HIV self-test and that the result was positive;
- the self-test result must be confirmed by a laboratory test;
- protect yourself and protect others.

Warnings
If you believe that exposure to HIV may have occurred within the last 3 months, a negative test result is not certain at this time. Therefore, avoid any activity that could cause HIV transmission to others. Use a condom to protect yourself and your partners. It will be necessary to repeat the self-test after 3 months from the most recent risk of HIV exposure.
- The self-test is intended for strictly private use as an HIV self-test and must not be used for other diagnoses or purposes under any circumstances.
- The self-test must be used only with a freshly collected capillary blood sample, following the instructions contained in this document. Do not use for serum or plasma samples.
- The self-test is a single-use device. Do not reuse.
- Do not open the aluminum pouch containing the self-test until the time of testing.
- This self-test should not be used for the follow-up of patients on antiretroviral therapy.
- Anyone using this self-test should consult their doctor before making any treatment decisions, regardless of whether a positive or negative result has been obtained.
- False positive (0.2% in studies on test specificity) or false negative results may be due to the following circumstances: exposure to HIV within three months prior to test use (window period), advanced immunodeficiency situations or infection with a rare variant, or testing on seropositive subjects on antiretroviral therapy.
- The test result could also be wrong due to improper storage of the product according to instructions or non-compliance with usage limitations.
- Do not use the self-test if the package or aluminum pouch has been opened or damaged.
- Do not use the self-test if the expiry date indicated on the package has been exceeded.
- In case of difficulty understanding the explanations on the package or the instructions for use, contact Mylan immediately at: +39 02 61246462.
- Keep the self-test and all package contents out of reach of children. The components of Autotest VIH can be dangerous if swallowed and may cause irritation.
- Autotest VIH offers an additional method of HIV testing that can be used as a complement to other existing options. Autotest VIH can only diagnose HIV infection and cannot be used to test for other sexually transmitted diseases.
- AAZ-LMB expressly disclaims any responsibility related to the use or distribution of Autotest VIH or any of its components, if not in strict compliance with the indications and usage limits specified in the instructions for use.

Storage
Store the self-test in its original packaging in a cool, dry place at a temperature between 8°C and 30°C. Keep away from sunlight.

Format
- 1 aluminum pouch containing: 1 self-test, 1 cap containing buffer solution, 1 safety lancet, 1 plaster;
- 1 test tube holder;
- 1 sterile gauze;
- 1 disinfectant wipe;
- 1 instruction leaflet.